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Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5

EUDAMED

Class I (EU MDR)

Ref ELDSC-5

by Somatics, LLC

Identity

Trade Name
Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5 EUDAMED
Device Name
Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5 EUDAMED
Model / Reference
ELDSC-5 EUDAMED

Identifiers

Primary DI / UDI-DI
00850298007089 EUDAMED
Basic UDI-DI
0850298007089F EUDAMED
EMDN Code
C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Cardiac radio-frequency ablation system catheter

Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 5 by Somatics, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac radio-frequency ablation system catheter.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Somatics, LLC
EUDAMED SRN
US-MF-000011550
Authorised Representative
FBI Medizintechnik GmbH DE-AR-000009421

Sources (1)

  • EUDAMED c51beedf-8f1b-4c96-961a-79cca0dcd036 61 fields · synced Jul 14, 2026